Kornimate/medical-research-clean huggingface dataset:
evaluation of a polymeric plate derived from castor oil to thermotherapy

Conditions: Therapeutic Hyperthermia; Thermotherapy; Polymers

Summary: the objective of this work is to evaluate, from volunteers viewpoint, the usability, comfort, appearance, weight, superficial temperature, and other characteristics of a polymeric plate derived from castor oil developed to thermotherapy. the volunteers will use polymeric plate as a therapeutic resource in the shoulder area and then fill in, without interference of the researcher, some questions about the characteristics of interest.

in this study, the polymeric plate is prepared using the following procedure: 1. - the water is heated to the boiling temperature 2. - the heater is shut down 3. - the polymeric plate is immersed in water 4. - it rests in the water for 15 minutes 5. - it is inserted in a wrap in this condition, the polymeric plate is placed on the shoulder of the volunteer and remains there for 20 minutes. after application, the volunteer answers the questionnaire containing eight questions on a likert scale (0 to 10) and an area of observations. previous laboratory tests were performed to ensure that the temperature of the polymeric plate will not cause skin burn in this application condition.

Eligibility criteria:
inclusion criteria: * good communication and comprehension * skin integrity exclusion criteria: * reduced skin sensitivity * disturbance in the central nervous system

Keywords: therapeutic hyperthermia thermotherapy polymers castor oil
evaluation of an intervention for adolescent girls in karnataka

Conditions: Secondary School Entry and Completion; Child Marriage

Summary: this cluster randomised control trial is evaluating an intervention to support adolescent girls from marginalised communities in northern karnataka state, south india to complete secondary school, thereby reducing their vulnerability to hiv infection from early marriage and entry into sex work at young ages. the intervention will test innovations to address both supply and demand side barriers to girls' completion of secondary school, and will have long-term educational and livelihood benefits, in addition to reducing vulnerability to hiv. school-based constraints will be addressed by improving academic outcomes through teacher training and academic support to students; addressing gender-related and skill-based gaps among teachers; training of local female teachers; and increasing the content knowledge of secondary school teachers. demand side barriers will be addressed by reducing economic pressures that households face to withdraw girls' from school; building appreciation and value of girls' education; building family and community accountability for school attendance; creating safe spaces for girls and strengthening their agency; and engaging boys in promoting and supporting girls' education. primary stakeholders will include teachers and students, especially adolescent girls in the school (7th to 10 the standard) from marginalized communities. secondary stakeholders will include school development and management committees (sdmcs), families, boys and the communities that are served by the schools. 80 village clusters (40 intervention; 40 control) were randomly selected from 125 village clusters in bagalkote and vijayapura districts. the intervention will be implemented with village communities and high schools in 40 village clusters in bagalkote and vijayapura districts. the intervention will be implemented in collaboration with the department of state educational research and training (dsert), karnataka; the adolescent education cell, government college of teachers' education (cte), jamkhandi; and the institute for advanced studies in education (iase), gulbarga.


Eligibility criteria:
inclusion criteria: * adolescent girls in standard 7 exclusion criteria: * none

Keywords: adolescent girls female sex work age at marriage retention in school sexual debut india karnataka
effect of sleep restriction on decision making and inflammation

Conditions: Sleep Deprivation

Summary: * hypothesis: sleep restriction in healthy subject trigger alteration of decision making associated with immuno-inflammatory changes * inclusion criterias: healthy subjects, men, under 35 years, bmi\<26, no sleep troubles, intermediate chronotype * design: 12 subjects, longitudinal study 2 days of baseline, 7 night of sleep restriction (4h sleep/night), recovery (1, 2, 3 and 9 normal sleep nights). * parameters: decision making tests, reaction time, wakefulness test, biological parameters (cathecholamines, pro-inflammatory cytokines...), heart rate, blood pressure * control of sleep restriction: continuous polysomnographic survey


Eligibility criteria:
inclusion criteria: * healthy men, \< 35 yr old, bmi\<26, intermediate chronotype exclusion criteria: * sleep trouble, acute or chronique disease (cardiological, neurological...), women

Keywords: sleep restriction, decision making, wakefullness
inpatient diabetes on corticosteroids

Conditions: Diabetes Mellitus

Summary: despite a significant problem with out-of-control glucose levels in patients with diabetes receiving corticosteroids for a variety of illnesses, there are no published protocols addressing how to adequately treat corticosteroid-induced hyperglycemia. investigators propose to test a protocol using scheduled dosing of nph (neutral protamine hagedorn) insulin for inpatients with diabetes receiving corticosteroids. nph insulin action is ideally timed to counteract corticosteroid-induced hyperglycemia, and the dose is added to the patient's usual insulin regimen and timed to correspond to the corticosteroid dosing regimen. investigators will prospectively enroll eligible consented patients with diabetes who are receiving corticosteroids as part of their treatment in a large county hospital, will randomize them to intervention or control groups, and will monitor their glucose levels during their inpatient stay. the protocol will demonstrate improved control of glucose levels with minimal risk of hypoglycemia, and will provide a practical and readily implementable protocol using nph insulin as therapy for corticosteroid-induced diabetes.

as above.

Eligibility criteria:
inclusion criteria: * prior history of diabetes * able to provide informed consent * receiving corticosteroids while hospitalized of greater than 10 mg/d prednisone or the equivalent of dexamethasone or methylprednisolone * expect to be hospitalized for 48 hours exclusion criteria: * renal failure with gfr (glomerular filtration rate) \< 30 ml/min/1.73m2 * alt (alanine aminotransferase) \> 2 times upper normal for laboratory

Keywords: corticosteroid diabetes insulin
caregiver burden and wellbeing in relatives of intensive care unit patients

Conditions: Social Responsibility

Summary: the purpose of this study is to determine whether there is an association between adverse physical and/or psychological outcome in icu survivors and the caregiver burden for their relatives. we hypothesize that relatives to icu survivors with an incomplete physical and/or psychological recovery three months after icu stay report a higher caregiver burden.

this is a sub-study to the multicenter "progress study". details of the progress study have been described elsewhere. briefly, an observational study including 600-1000 adult icu patients from ten european hospitals will be followed up during three months to identify potential risk factors for physical and psychological problems. the sub-study is conducted in four swedish hospitals (karolinska university hospital solna, södersjukhuset, stockholm, örebro university hospital and akademiska university hospital in uppsala). relatives to patients included in the progress study, who give informed consent to participate are consecutively included in the study. consenting participants (relatives) will be approached after inclusion of the patient and asked to estimate their own health related quality of life (hrqol) 2 weeks prior to the time point for patient icu admission through a hrqol questionnaire. this self-reported hrqol data will be used as proxy for baseline data. three months after icu discharge, relatives to icu survivors will receive the following questionnaires by postal mail; caregiver burden index, hrqol questionnaire, a questionnaire screening for symptoms of anxiety and depression and a questionnaire screening for symptoms of posttraumatic stress. the relatives will also be asked to state the number of working days lost due to caretaking of the icu survivor. icu survivors' physical and psychological outcome, assessed with bi, sf-36, ptss-14 and hads three months after icu discharge, obtained in the main progress study, will be compared with relatives' reported caregiver burden. secondary outcomes are associations between caregiver burden and reported health-related quality of life between baseline and 3 months after icu discharge, frequency of symptoms of anxiety, depression and posttraumatic stress 3 months post icu discharge and number of working days lost because of their relative's critical illness.

Eligibility criteria:
inclusion criteria: 1. relatives are considered eligible if they are a) partner to the patient b) adult children, siblings, parents or close friend that share household with the icu survivor exclusion criteria: 1. non-swedish-speaking 2. overt or documented cognitive impairment

Keywords: caregiver burden index
intravenous ascorbic acid supplementation in neoadjuvant chemotherapy for breast cancer

Conditions: Breast Cancer

Summary: forty years ago clinical studies conducted by ewan cameron and linus pauling suggested that intravenous (iv) and oral ascorbic acid (aa) may diminish symptoms and could improve survival in terminal cancer patients. previous phase i and ii clinical trials have found that high dose (1.5g/kg ) iv aa is well tolerated in cancer patients. this is a phase i/ii, randomized study of parenteral administration of ascorbic acid (aa) as a supplement to the conventional neo-adjuvant chemotherapy in women with breast cancer.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status score ≤2; * diagnosed high-risk breast cancers (tumours ≥ 2cm and/or locally advanced breast tumors) and scheduled to receive neoadjuvant chemotherapy; * agree to avoid any additional supplemental ascorbic acid throughout the study; * normal glucose-6- phosphate dehydrogenase (g6pd) activity; * normal renal function (serum creatinine ≤ 1.2 mg/dl) and normal liver function; * no evidence of urolithiasis; * no evidence of chronic hemodialysis, iron overload (serum ferritin 500 ng/ml); * not pregnant or lactating women exclusion criteria: * important psychosomatic diseases or known gastrointestinal disorders (ulcer, gastritis, colitis, ileitis); * current smoking and/or alcohol consumption ≥ 3ui per day; * current use of the following drugs: aspirin (exceeding 325 mg/day) acetaminophen (exceeding 2 g/day) glutathione vitamin d (important doses)

Keywords: breast cancer ascorbic acid vitamin c vitamin supplementation quality of life
the results of pancreatic operations after the implementation of multidisciplinary team conference (mdt):

Conditions: Pancreatic Neoplasms

Summary: background: centralization has improved the outcome of complex operations including cancer surgery. moreover, the implementation of multidisciplinary team conferences (mdt) has ameliorated the decision making, but the impact on patient outcome is controversial. the aim of the study was to investigate the outcome of pancreatic surgery in the setting of centralization and upfront multidisciplinary decision making.

study is a retrospective register study from a prospective database over mdt conferences and patient outcome. end points are quality evaluation regarding postoperative complications and mortality and long-term survival of patients radically operated for pancreatic cancer.

Eligibility criteria:
inclusion criteria: all gender seen at multidisciplinary team conference (mdt) exclusion criteria: all gender not seen at mdt - -
a study of vonapanitase (prt-201) administered immediately after radiocephalic arteriovenous fistula(avf) creation in patients with chronic kidney disease (ckd) (patency-2)

Conditions: Chronic Kidney Disease

Summary: this research study is designed to assess the safety and effectiveness of an experimental drug called vonapanitase (prt-201) in patients both receiving or expecting to receive hemodialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. vonapanitase is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (avf). the purpose of this study is to determine whether vonapanitase when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your avf.


Eligibility criteria:
inclusion criteria: 1. age of at least 18 years. 2. life expectancy of at least 6 months. 3. diagnosis of ckd. 4. planned creation of a new radiocephalic avf (revision of an existing avf is not eligible). 5. ability to understand and comply with the requirements of the entire study and to communicate with the study team. 6. written informed consent using a document that has been approved by the institutional review board (irb) or independent ethics committee (iec). 7. if female and of childbearing potential (premenopausal and not surgically sterile) must have a negative serum pregnancy test at the screening visit and be willing to use contraception from the time of the screening visit to 2 weeks following study drug administration. acceptable methods of birth control include abstinence, barrier methods, hormones, or intra-uterine device. exclusion criteria: 1. malignancy or treatment for malignancy within the previous 12 months with the exception of the following cancers if they have been resected: localized basal cell or squamous cell skin cancer, or any cancer in situ. 2. presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study. 3. previous treatment with vonapanitase (prt-201). 4. treatment with any investigational drug within the previous 30 days or investigational antibody therapy within the previous 90 days prior to signing informed consent.

Keywords: radiocephalic arteriovenous fistula avf hemodialysis prt-201 vonapanitase vascular access kidney renal patency-2 secondary patency fistula abandonment use for hemodialysis
a study to assess en3835 in the treatment of plantar fasciitis (pfa)

Conditions: Plantar Fasciitis

Summary: this study will assess the efficacy, safety, and tolerability of 2 different doses of en3835 compared to placebo.


Eligibility criteria:
key inclusion criteria: * have no significant medical history or examination findings related to the foot to be treated, which in the investigator's opinion, would make the participant unsuitable for study intervention administration. * have a diagnosis of plantar fasciitis for ≥6 months, which has not responded to conservative therapies. conservative therapies may include rest, physical therapy, splinting/bracing, orthotics, icing, physiotherapy, acetaminophen, corticosteroids, or nonsteroidal anti-inflammatory drugs (nsaids). * have current foot pain due to plantar fasciitis. key exclusion criteria: * has any musculoskeletal, neuromuscular, neurosensory, other neurological or related disorder that affects the participant's use of his/her feet and/or would impair his/her completion of study assessments as determined by the investigator either due to the disorder or due to pain. * has a clinically meaningful laboratory abnormality. * has a body mass index ≥35 kilograms per meter squared (kg/m\^2). * has a known bleeding disorder, which, in the investigator's opinion, would make the participant unsuitable for enrollment in the study.
sleep schedules modifications in sleep apnea patients treated by ncpap

Conditions: Obstructive Sleep Apnea

Summary: in obstructive sleep apnea (osa) patients, sleep is disrupted and sleep quality is very poor. the investigators can suppose that with continuous positive airway pressure (cpap) therapy, there is an improvement in sleep quality, such that patients need less sleep to be fit. sleep schedules on mid term periods in osa patients under cpap therapy has not been studied. the investigators have planned to study sleep schemes before and after cpap therapy in moderate to severe sleepy osa patients.

in obstructive sleep apnea (osa) patients, sleep is disrupted and sleep quality is very poor. the investigators can suppose that with cpap therapy, there is an improvement in sleep quality, such that patients need less sleep to be fit. patients often report this fact, but it has not been objectivated. sleep schedules on mid term periods in osa patients under cpap therapy has not been studied. the investigators have planned to study sleep schemes before and after cpap therapy in moderate to severe sleepy osa patients. sleep schemes and physical activity will be studied with actigraphy. study design : prospective study. number of patients supposed to be studied: 190 methods: patients ø osa patients assessed by polysomnography, showing apnea-hypopnea index \> 20, and epworth sleepiness scale score(ess) \>10 ø indication of cpap therapy initial evaluation : * phase 1 * ess * bmi * questionnaire : nottingham health profile * comorbidities -medical therapy * smoking/alcohol consumption * then, we give an actigraph (body media sense wearò) to the patients, that he has to wear during 7 complete days * phase 2 * actigraphy report * start of cpap therapy(pressure adjusted according to autocpap device report after minimum one night) second evaluation, after 3 months under cpap: * phase 1 § ess * bmi * cpap observance report to calculate mean use/day * questionnaire : nottingham health profile * actigraph (body media sense wearò) to the patients, that he has to wear during 7 complete days * phase 2: after 1 week under cpap and actigraphy * actigraphy report * cpap observance report * cpap tolerance questionnaire ø

Eligibility criteria:
inclusion criteria: * moderate to severe osa * sleepy (sleepiness assessed by epworth sleepiness scale) * indication for cpap therapy exclusion criteria: * narcolepsy * age \< 18 * non sleepy moderate to severe osa * no cpap treatment required

Keywords: obstructive sleep apnea cpap actigraphy sleep physical activity
a phasei study of hl-085 plus vemurafenib in solid tumor with braf v600 mutation

Conditions: Solid Tumor

Summary: this is a phase i, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetics and efficacy in patients with braf v600 mutant advanced solid tumor by hl-085 plus vemurafenib treatment.


Eligibility criteria:
inclusion criteria: 1. braf v600 mutation in solid tumor. 2. one measurable lesion as defined by recist 1.1 criteria for solid tumors. 3. chemotherapy, immunotherapy or radiotherapy ≥ 4 weeks prior to starting the study treatment. 4. surgery (except for tumor biopsy) or severe trauma ≤ 14 days prior to starting the study treatment. 5. ecog performance status of 0-1. 6. life expectancy ≥ 3 months. 7. ability to take the medicine orally. 8. ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. hypersensitivity to study drug ingredients or their analogues. 2. prior therapy with mek-inhibitor. 3. receiving any other anti-cancer therapy at the same time . 4. active central nervous system (cns) lesion. 5. bleeding symptoms at grade 3 within 4 weeks prior to starting study treatment. 6. ecg qtcb≥480msec in screening, or history of congenital long qt syndrome； 7. uncontrolled concomitant diseases or infectious diseases. 8. retinal diseases (retinal vein occlusion (rvo) or retinal pigment epithelial detachment (rped) , et al.). 9. history of hiv,hcv,hbv infection. 10. interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis will be excluded. 11. serum hcg test is positive. 12. other conditions that increase the risk of study and influence the result.
pharmacy-based interdisciplinary program for patients with chronic heart failure

Conditions: Chronic Heart Failure

Summary: the aim of the study is to investigate whether a continuous interdisciplinary intervention improves medication adherence (primary efficacy endpoint) and leads to a reduction of hospitalizations and mortality (primary safety endpoint) in elderly patients with chronic heart failure. the intervention, consisting of regular contacts with the local pharmacy and weekly dosing aids, aims to improve medication adherence and management.


Eligibility criteria:
inclusion criteria: * age: 60 years and older * chronic heart failure (chf) * stable chf medication including a diuretic * hospitalization for decompensated heart failure within past 12 months or a value of ≥ 350 pg/ml for bnp or ≥ 1,400 pg/ml for nt-probnp * written informed consent exclusion criteria: * use of a weekly dosing aid * unwillingness or inability to visit a participating pharmacy once a week * planned cardiac surgery * life-expectancy \< 6 months * unwillingness or inability to comply with the study protocol (including drug abuse or alcohol dependency) * participation in other studies (currently or in the last 4 weeks)

Keywords: chronic heart failure medication adherence pharmacy interdisciplinary care randomized controlled trial mortality hospitalization